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Session 5, Track C: Notification of Foreign Actions: Challenges and Best Practices
Session Chair(s)
Nadia Mian, MS
Pharmacovigilance Manager
Ipsen Biopharmaceuticals Canada Inc., Canada
Nadiya Jirova, MSc
Manager, Bureau of Biologics, Radiopharmaceuticals and Self-Care Products
Health Canada, Canada
Agnes Jankowicz, MS
Vice President, Pharmacovigilance
Veristat, Canada
Health Canada first published the Notifying Health Canada of Foreign Actions guidance in November 2018. As industry has now had some time to become familiar with this requirement, this session will provide an update on Health Canada’s experience with Notifications of Foreign Actions (NFA) process, provide practical feedback on the process and identify potential areas for improvement and collaboration with the industry. The session will also provide perspective from industry on best practices when dealing with actions from foreign regulators. Attendees will also be able to ask specific questions to Health Canada representatives.
Speaker(s)
Notification of Foreign Actions: An Update by Health Canada
Bruce Wozny, MA
Health Canada, Canada
Sr. Policy Officer, Health Products and Food Branch, Marketed Health Products
Foreign Alerts: An Industry Perspective
Randy Levitt, PhD
Paladin Labs Inc., Canada
Director, Pharmacovigilance and Medical Affairs
Good Pharmacovigilance Practices (GVP) Inspections: Notification of Foreign Actions
Koby Philip-Joseph
Health Canada, Canada
Regional Regulatory Compliance and Enforcement Officer
Speaker
Paul Baillargeon
Health Canada, Canada
Regional Regulatory Compliance and Enforcement Specialist, Health Product
Notification of Foreign Actions: An Update by Health Canada
Andrea Bell, PhD
Health Canada, Canada
Human Therapeutic Product Submission Assessment Evaluator